- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00674661
Corneal Collagen Cross-Linking for Ectasia (CXL) (CXL)
April 22, 2021 updated by: Glaukos Corporation
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery
Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit.
Corneal collagen cross-linking is performed as a single treatment.
Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 92093
- Shiley Eye Center
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San Diego, California, United States, 91222
- Gordon -Weiss Vision Institute
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Florida
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Miami, Florida, United States, 33176
- Center for Excellence in Eye Care
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Indiana
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Indianapolis, Indiana, United States, 46260
- Price Vision Group
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Kansas
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Kansas City, Kansas, United States, 66211
- Durrie Vision
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Maryland
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Baltimore, Maryland, United States, 21287
- Wilmer Eye Institute at Johns Hopkins University
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Minnesota Eye Consultants
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New Jersey
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Teaneck, New Jersey, United States, 07666
- Cornea & Laser Eye Institute; Hersh Vision Group
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New York
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New York, New York, United States, 10032
- Edward Harkness Eye Institute at Columbia University Medical Center
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Rockville Centre, New York, United States, 11570
- Ophthalmic Consultants of Long Island
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of ectasia after refractive surgery
- Documented ectasia on Pentacam or topography map
- BSCVA worse than 20/20
- Must complete all study visits
Exclusion Criteria:
- History of delayed wound healing
- History of corneal melt or corneal dystrophy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Corneal Collagen Cross-linking (CXL) Treatment Group
riboflavin ophthalmic solution and UVA irradiation
|
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
Other Names:
|
Sham Comparator: Control Group
riboflavin opthalmic solution without UVA irradiation
|
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Maximum Keratometry (Kmax)
Time Frame: baseline,12 months
|
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes.
Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group.
Keratometry was measured manually and by pentacam.
|
baseline,12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
May 6, 2008
First Submitted That Met QC Criteria
May 6, 2008
First Posted (Estimate)
May 8, 2008
Study Record Updates
Last Update Posted (Actual)
April 26, 2021
Last Update Submitted That Met QC Criteria
April 22, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UVX-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Glaukos CorporationWithdrawn
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Stephen TrokelNo longer available
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Cornea and Laser Eye InstituteCompleted
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Stephen TrokelWithdrawn
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Robert Mack, M.D.UnknownKeratoconus | Corneal EctasiaUnited States
-
American-European Congress of Ophthalmic SurgeryTerminatedKeratoconus | Corneal EctasiaUnited States, Puerto Rico
-
Singapore Eye Research InstituteUnknownKeratoconus | Post LASIK KeratectasiaSingapore